electrical vestibular nerve stimulation (vens) as a treatment for anxiety: a randomized clinical trial

Conditions: Anxiety

Summary: the present study will be conducted at the department of physiology in collaboration with the department of psychiatry of r.d. gardi medical college, ujjain, madhya pradesh. this double-blind randomized controlled trial will remotely enroll 60 subjects. each participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. each session will be 30 minutes on the day of usage. the study will be randomized with a 1:1 active; or sham control allocation. endpoint analysis will be performed upon completion of the study.


Eligibility criteria:
inclusion criteria: * signed informed consent * report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the generalized anxiety disorder scale, 7th edition (gad-7) * males or females 18-80 years of age inclusive on starting the study * can speak/read english * ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis * not using, and have never used, prescription, or the counter, anxiety medications * agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes exclusion criteria: * history of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears. * previous diagnosis of hiv infection or aids (hiv is known to cause a vestibular neuropathy which would prevent the modius stress device from working) * medication for anxiety * use of beta-blockers within 1 month of starting the study * use of antidepressants or unstable dose within 3 months of starting study * use of any other medical condition or medication use that in the opinion of the pi is likely to make the participant resistant to vens. * a score higher than 14 on the insomnia severity index (isi) * a history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (in case this damaged the neurological pathways involved in vestibular stimulation). * presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.). * pregnancy or breast-feeding or intends to become pregnant (a pregnancy kit can be mailed if any uncertainty) * history of epilepsy * history of active migraines with aura * history of head injury requiring intensive care or neurosurgery * history of diagnosed cognitive impairment such as alzheimer's disease/dementia * history of bipolar, psychotic or substance use disorders * diagnosis of a current psychotic disorder * regular use (more than twice a month) of antihistamine medication within the last 6 months. * history or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas) * a diagnosis of myelofibrosis or myelodysplastic syndrome. * previous use of any vens device * participation in other clinical trials * history of vestibular dysfunction or another inner ear disease